BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4802497 · Received May 26, 2015

    Report

    Report Number
    1314492-2015-06259
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 30, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REC'D BY BAXTER FOR EVAL. THE EVAL HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DELIVERED MORE THAN THE PROGRAMMED AMOUNT DURING VOLUMETRIC TESTING. USING WATER AS THE FLUID, THE DELIVERY RATE WAS PROGRAMMED AT 200 ML/HR FOR 15 MINUTES. AFTER THE 15 MINUTES, IT WAS STATED THAT >100 ML WAS COLLECTED. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341214 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1